Polysomnographic Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01485393
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 10
• Location: 1
• Arms: 2
• Duration (Months): 41.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether dexmedetomidine can be used to induce normal physiological sleep in humans.

Condition or Disease	Intervention/Treatment	Phase
Insomnia	Drug: Dexmedetomidine; Drug: Zolpidem	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Patients will receive both interventions in a randomized order.Patients will receive both interventions in a randomized order.
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pilot Study Comparing the Use of Dexmedetomidine and Zolpidem to Induce Natural Sleep
• Study Start Date: Jan 1, 2015
• Actual Primary Completion Date: Jan 29, 2018
• Actual Study Completion Date: Jun 29, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Healthy Control Subjects: Zolpidem, Then Dexmedetomidine This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.	Drug: Dexmedetomidine; A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).; Other Names: Precedex ; Drug: Zolpidem; 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
Experimental: Healthy Control Subjects: Dexmedetomidine, Then Zolpidem This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.	Drug: Dexmedetomidine; A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).; Other Names: Precedex ; Drug: Zolpidem; 12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).

Outcome Measures

Primary Outcome Measures

1. Change in Sleep Quality [Approximately 8 hours]

   Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.

Secondary Outcome Measures

1. Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep [Approximately 30 minutes after waking up]

   The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Primary Inclusion Criteria for "Insomniac" subjects:

Subjects will be deemed "Insomniacs" if they suffer from any of the following:

1. Subject will be required to meet the criteria for insomnia, set by the International Classification of Sleep Disorders, which requires that a patient have difficulty initiating or maintaining sleep that is not accounted for by another sleep disorder, neurologic or psychiatric disorder or substance or medication.

2. Subject will be required to not be on any current pharmacological sleep disorder treatment.

3. Between the ages of 18 and 35 years.

4. Not taking any prescription medications that alter sleep, cognitive functions, or both.

Exclusion Criteria:

Primary Exclusion Criteria for "Healthy" control subjects:

1. Abnormal sleep habits:

• sleeping less than 5 hours each night;

• going to sleep before 9:00 PM or after 2:00 AM on a regular basis; or

• Waking up before 5:00 AM or after 10:00 AM on a regular basis. This will be objectively assessed by wrist actigraphy measured for a 1-week duration prior to the first study night.

1. A sleep latency greater than 60 minutes, greater than 3 awakenings per night. This will also be objectively assessed by wrist actigraphy.

2. A score greater than or equal to 10 on the Epworth Sleepiness Scale.

3. Takes medication that alters sleep, cognitive function, or both.

4. Has a history of a known neurological or psychiatric problem.

5. Younger than 18 or older than 35 years of age.

6. Known or suspected sleep disorder(s).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• National Institutes of Health (NIH)

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Nov 9, 2017

More Information

Publications

None provided.

• Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Assistant in Anesthaesia, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01485393
• Other Study ID Numbers: 2011P-000715; DP1OD003646
• First Posted: Dec 5, 2011
• Last Update Posted: Oct 8, 2019
• Last Verified: Oct 1, 2019

• Additional relevant MeSH terms: Sleep Initiation and Maintenance Disorders; Dexmedetomidine; Zolpidem

Study Results

Participant Flow

Arm/Group Title	Healthy Control Subjects: Zolpidem, Then Dexmedetomidine	Healthy Control Subjects: Dexmedetomidine, Then Zolpidem
Arm/Group Description	This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Zolpidem induced-sleep and then a night of Dexmedetomidine induced-sleep.	This arm will enroll healthy control subjects, who will receive a regular nights sleep followed by a night of Dexmedetomidine induced-sleep and then a night of Zolpidem induced-sleep.
Period Title: Overall Study
STARTED	5	5
COMPLETED	5	5
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	All Study Participants
Arm/Group Description	All study participants who were either randomized to receive either Dexmedetomidine or Zolpidem initially.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	23.9
Sex: Female, Male (Count of Participants)
Female	4 40%
Male	6 60%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
United States	10 100%

Outcome Measures

1. Primary Outcome

Title	Change in Sleep Quality
Description	Sleep quality will be assessed objectively through EEG measures (changes from baseline in length of non-REM sleep, length of REM sleep, and length of N3 sleep--all assessed in minutes) and subjectively, utilizing a post sleep questionnaire to assess the difference in quantity of sleep (minutes) from baseline. Sleep quality is directly related to these measures of sleep quantity.
Time Frame	Approximately 8 hours

Outcome Measure Data

Analysis Population Description

All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.

Arm/Group Title	Zolpidem-Induced Sleep	Dexmedetomidine-Induced Sleep
Arm/Group Description	All healthy control subjects undergo a night of zolpidem-induced sleep.	All healthy control subjects undergo a night of dexmedetomidine-induced sleep.
Measure Participants	10	10
Changes in total non-REM sleep	33.2	0
Changes in REM sleep	-35	0
Changes in N3 sleep	35.8	26.8
Subjective differences in sleep	0	0

2. Secondary Outcome

Title	Performance on a Psychomotor Vigilance Test (PVT) After Waking up From Sleep
Description	The PVT is a measure of reaction time. It is measured as Lapse 400, which is the number of responses on the PVT greater than 400 milliseconds.
Time Frame	Approximately 30 minutes after waking up

Outcome Measure Data

Analysis Population Description

All patients undergo both zolpidem- and dexmedetomidine-induced sleep. Data analysis for this cohort was performed irrespective of randomization order.

Arm/Group Title	Zolpidem-Induced Sleep	Dexmedetomidine-Induced Sleep
Arm/Group Description	All healthy control subjects undergo a night of zolpidem-induced sleep.	All healthy control subjects undergo a night of Dexmedetomidine-induced sleep.
Measure Participants	10	10
Number [responses]	26	12

Adverse Events

Time Frame	Through completion of all three study visits (approximately 2 weeks).
Arm/Group Title	Zolpidem		Dexmedetomidine
Arm/Group Description	This arm reflects the night of Zolpidem-induced sleep for all 10 participants.		This arm reflects the night of Dexmedetomidine-induced sleep for all 10 participants.
All Cause Mortality
	Zolpidem		Dexmedetomidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Serious Adverse Events
	Zolpidem		Dexmedetomidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Zolpidem		Dexmedetomidine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

Insomniac patients were not conducted as originally proposed due to difficult enrollment. The Motor Sequence Task was not performed as originally proposed, so it has been removed as a secondary outcome measure.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.